TrialX Reviews & Product Details

Advarra eReg is a secure, paperless electronic Investigator Site File (eISF) system that integrates with Advarra's CTMSs--OnCore and Clinical Conductor. This centralized document management solution helps research sites improve productivity, accelerate study startup, and strengthen regulatory compliance through features such as streamlined document routing, real-time alerts for new documents, and electronic signature capabilities via Advarra eConsent. In addition to CTMS integration, Advarra eReg connects with Advarra’s CIRBI system, and internal site email systems to create a fully integrated research ecosystem. For sites transitioning to eReg, Advarra offers automated document migration, ensuring a seamless transfer of existing files and enabling immediate value from its connected technology platform.

Microsoft Genomics offers a cloud implementation of the Burrows-Wheeler Aligner (BWA) and the Genome Analysis Toolkit (GATK) for secondary analysis. The service is ISO-certified and compliant with HIPAA regulations, and offers price predictability for your genome sequencing needs.

AmpleLogic Annual Product Quality Review (APQR) Software is a web and cloud based application that eliminates the need for a paper based documentation required for review of every batch product manufactured

Life Sciences companies include Pharmaceutical, Contract Development and Manufacturing Organization (CDMO), Biotechnology, Contract Research Organization (CRO) and Biosimilars continue to operate in a highly competitive environment. The Quality Control (QC) laboratory in a pharmaceutical company plays a critical role in the testing of Raw Materials, Stability, In-process and FG Samples. QC Analysts from different sections analyze incoming samples of different kinds. These include Finished Goods (FG), in-process products, stability samples, and environmental samples. Analysts may also be required to analyze raw materials. In organizations with diversified drug products, the number of samples to be tested per week will range from 150 – 400 Samples and each sample must go through a minimum of 6 tests. In such a scenario it is a challenge to prioritize the samples and assign equipment like HPLC/GC to the QC Analyst manually. HOD’s of QC Labs are under steady pressure to improve the lab operations in order to meet the Sample TAT (Turn Around Time). The equipment used in the Pharmaceutical and Biotech product testing are highly sophisticated, extremely sensitive, and very expensive. Maximizing both staff (Laboratory technicians and managers) time and machine time is essential in the QC lab to address the problems of varying demands and to maximize resource efficiency. Consequently, Planners/Managers are finding a way to move towards lean QC lab by improving their processes, improving effective utilization of resources, reducing lead times, and at the same time, increasing reliability by accelerating authorization processes for compliance. This affects both production and batch release. A good Quality Control Planning describes how an organization will achieve its quality goals by specifying the quality assurance and control activities which are performed as part of daily lab operations

Study eSafe is a document control software that provides sites with an intuitive and streamlined system to digitally manage all the regulatory documents.